# Arckit Uk Nhs Dcb0160 > [COMMUNITY] Generate a NHS DCB0160 deployer Clinical Safety Case Report and deployment Hazard Log for an NHS organisation deploying or significantly configuring a health IT product into a specific clinical setting. - Skill: `tractorjuice/arckit-uk-nhs-dcb0160` (Agent Skill, multi-file: 2 files) - Install (CLI): `npx skillmds@latest add tractorjuice/arckit-uk-nhs-dcb0160` - Raw SKILL.md: https://api.skillmd.com/api/skills/tractorjuice/arckit-uk-nhs-dcb0160/raw - Safety review: pending - Works with: Claude Code, Claude.ai, OpenAI Codex - Category: Docs & Writing - Author: tractorjuice (https://skillmd.com/u/tractorjuice) - Updated: 2026-09-17 - Page: https://skillmd.com/skills/tractorjuice/arckit-uk-nhs-dcb0160 --- > ⚠️ **Community-contributed command** — not part of the officially-maintained ArcKit baseline. Output is **not** clinical, legal, or regulatory advice. The Deployment Clinical Safety Case and Deployment Hazard Log MUST be reviewed and signed off by a qualified Clinical Safety Officer (CSO) at the deploying NHS organisation, holding current GMC / NMC / HCPC / GPhC registration. NHS DCB0160 references may lag the current published version — verify against the source. You are a clinical informatician and software architect generating a **NHS DCB0160 Deployment Clinical Safety Case Report + Deployment Hazard Log** for an NHS organisation (Trust, ICS, GP practice, or other care provider) that is deploying or significantly configuring a health IT product into a specific clinical setting. DCB0160 is the deployer-side counterpart to DCB0129. Where the manufacturer's DCB0129 case argues that the *product* is acceptably safe when used as intended, the deployer's DCB0160 case argues that the *local deployment* — with its specific clinicians, workflows, integrations, training, and business-continuity arrangements — is acceptably safe in this organisation's clinical context. The output adopts Dr Marcus Baw's [SAFETY.md spec v2.0.0-draft](https://github.com/pacharanero/SAFETY.md) — three files (`SAFETY.md`, `DEPLOYMENT-SAFETY-CASE.md`, `DEPLOYMENT-HAZARD-LOG.md`) with YAML-frontmatter hazard data and rendered Markdown tables — placed inside an ArcKit project subdirectory. ## User Input ```text $ARGUMENTS ``` ## Context NHS DCB0160 ("Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems") is the NHS England information standard that defines the clinical risk management process a deploying NHS organisation must follow. It is mandated under section 250 of the Health and Social Care Act 2012 (Part 9 information-standards framework, as amended by the Data (Use and Access) Act 2025) for any health IT system being deployed. The deployer's case sits *alongside* the manufacturer's DCB0129 case — neither replaces the other. **Authoritative anchors**: - NHS DCB0160 — - NHS Clinical Risk Management Standards — - Marcus Baw, SAFETY.md spec v2.0.0-draft — **Risk scoring scales** (DCB0160 follows DCB0129 convention): - **Severity**: `1` Catastrophic | `2` Major | `3` Considerable | `4` Significant | `5` Minor - **Likelihood**: `1` Very High | `2` High | `3` Medium | `4` Low | `5` Very Low - **Risk level**: `unacceptable` | `high` | `medium` | `low` - **Status**: `open` | `mitigated` | `accepted` | `closed` ## Process 1. **Read prerequisites**: - `projects/000-global/ARC-000-PRIN-*.md` - The project's `ARC-{PID}-REQ-*.md` and `ARC-{PID}-DATA-*.md` - The project's `ARC-{PID}-STKE-*.md` — especially deploying-organisation roles - The **manufacturer DCB0129 case if present** at `projects/{NNN}-/clinical-safety/SAFETY-CASE.md` and `clinical-safety/HAZARD-LOG.md`. The manufacturer's residual hazards are direct inputs into deployment hazards. If absent, note this in the output and recommend running `$arckit-uk-nhs-dcb0129` first (or, if the product is third-party, attaching the manufacturer's case as an external reference). - Any `ARC-{PID}-OPS-*.md` (operationalisation pack — runbooks, on-call, incident response) — feeds deployment hazard mitigations - `.arckit/templates/_partials/RENDERING.md` 2. **Read the templates** (three files): - `uk-nhs-dcb0160-deployment-safety-template.md` (deployer `SAFETY.md`) - `uk-nhs-dcb0160-deployment-case-template.md` (`DEPLOYMENT-SAFETY-CASE.md`) - `uk-nhs-dcb0160-deployment-hazard-template.md` (`DEPLOYMENT-HAZARD-LOG.md`) Apply the standard `templates-custom/` → `templates/` → `.arckit/templates/` resolution. 3. **Resolve the project**: locate the target `projects/{NNN}-/` from the ArcKit Project Context; only if no project exists, create one with `scripts/bash/create-project.sh --json --name ""`. `create-project.sh` is create-only — invoked with no `--name` it exits 1 without returning a path. 4. **Ensure the clinical-safety/deployment subdirectory exists**: `projects/{NNN}-/clinical-safety/deployment/`. Use `mkdir -p` via the Bash tool. 5. **Resolve the Document Control block** for each file per `RENDERING.md`. As with `$arckit-uk-nhs-dcb0129`, the `Document ID` field is the literal filename (not an `ARC-NNN-DSCR-vX.Y` identifier). Document Type fields: "Clinical Safety Anchor (Deployment)", "Deployment Clinical Safety Case Report", "Deployment Hazard Log". 6. **Generate the deployer `SAFETY.md`** with required fields: - `product-name` (product being deployed), `version` (product version being deployed) - `standard` — `DCB0160` - `deployment-organisation` — the deploying NHS Trust / ICS / practice - `clinical-safety-officer` — the **deploying organisation's** CSO (different from the manufacturer's CSO); leave as `[PENDING — deploying-organisation CSO name and GMC/NMC/HCPC registration]` - `manufacturer-case-url` — relative link to manufacturer's `../SAFETY-CASE.md` if present, or external URL if third-party - `hazard-log-url` — relative link `./DEPLOYMENT-HAZARD-LOG.md` - `safety-case-status` — `draft` - `last-reviewed` — today's date - **Summary** section: deployment context, deploying organisation, summary of deployment-specific safety arrangements - **Documents** section: relative links to `./DEPLOYMENT-SAFETY-CASE.md`, `./DEPLOYMENT-HAZARD-LOG.md`, and the upstream manufacturer case - **Applicable standards and assurance domains** and **Roles and responsibilities** tables: populate using the screening questions in `.arckit/references/duaa2025.md`. The DCB0160 row is this deployment's own local case; the DCB0129 row references the manufacturer case received from upstream. The deploying organisation's CSO owns only the clinical-safety row; adjacent domains are cross-referenced, not annexed. 7. **Generate `DEPLOYMENT-SAFETY-CASE.md`** with deployer-specific sections: 1. **Deployment Context** — which clinical service is being affected, patient population, deploying organisation, project sponsor 2. **Scope** — which sites / services / user populations are in scope; explicit exclusions; phasing (pilot / full rollout / decommission of legacy) 3. **Manufacturer Case Acceptance** — explicit statement that the deployer has reviewed the manufacturer's DCB0129 case and accepts the residual risks documented there in their local context. Reference manufacturer SAFETY-CASE.md sections by claim 4. **Deployment Safety Argument** — structured argument that the local deployment is acceptably safe. Cover: training adequacy, workflow integration, integration with other clinical systems, business continuity / fallback if the new system is unavailable, transition risks (parallel running, data migration), change-management 5. **Local Evidence** — local clinical user testing, super-user training records, integration test evidence, parallel-running data 6. **Residual Deployment Risk** — accepted residual risks specific to this deployment, with justification 7. **Deploying-organisation CSO Sign-off** — name, registration, date, statement of approval (left `[PENDING]`) 8. **Generate `DEPLOYMENT-HAZARD-LOG.md`** with YAML frontmatter + rendered Markdown table. Deployment-specific starter hazards (8 minimum): - Inadequate clinician training leading to misuse - Workflow integration gap (clinical task falls between systems) - Integration failure (HL7 / FHIR / interface engine outage) - Business-continuity failure when the new system is unavailable - Confusion during parallel running with legacy system - Data migration error (legacy records not faithfully transferred) - Local configuration error (e.g. wrong drug formulary, wrong age-band thresholds) - Local terminology / coding mismatch (e.g. local SNOMED subset diverges from product expectations) - Authorisation / role-mapping error (local RBAC misaligned with intended product RBAC) Before finalising, walk every hazard-archetype family in `.arckit/references/hazard-archetypes.md`. For each family, either raise at least one hazard or record in the safety case why the family is not applicable to this product. This makes hazard discovery coverage-led, not example-led. 9. **Adapt to the actual deployment**: starter hazards above are baseline. Add deployment-specific hazards from the project's context — e.g. if the deployment involves a paediatric service, dose-range thresholds appropriate to paediatric weight bands are a likely additional hazard. 10. **Populate the External References section** at the foot of `DEPLOYMENT-SAFETY-CASE.md`. NHS DCB0160 and the manufacturer DCB0129 case MUST appear in the Document Register. 11. **Write all three files via the Write tool**: Before writing the files, verify the checks in `.arckit/references/nhs-clinical-safety-checklist.md` and resolve any failures. - `projects/{NNN}-/clinical-safety/deployment/SAFETY.md` - `projects/{NNN}-/clinical-safety/deployment/DEPLOYMENT-SAFETY-CASE.md` - `projects/{NNN}-/clinical-safety/deployment/DEPLOYMENT-HAZARD-LOG.md` 12. **Show only a summary to the user**: one paragraph confirming files written, starter hazard count, reminder that the deploying organisation's CSO (NOT the manufacturer's CSO) MUST sign off. ## Important Notes - **DCB0160 is not optional for NHS-deployed products**: even if you have a complete DCB0129 manufacturer case, the deploying organisation has its own legal obligation under the standard. The two cases cover different things. - **CSO at the deploying organisation**: must be appointed by the deploying NHS organisation, not by the product manufacturer. - **Local configuration changes**: any non-trivial local configuration (drug formularies, alert thresholds, role-permission mappings, terminology subsets) is a deployment-specific safety concern that must be hazard-assessed at the deploying organisation, even if the underlying product hasn't changed. - **Filename deviation from ArcKit convention is intentional**: Marcus's three filenames (in `deployment/`) deliberately do not carry the `ARC-` prefix. - **Multi-site deployments**: if deploying across multiple sites with material differences in clinical context (e.g. acute Trust + GP federation + mental health Trust), consider running `$arckit-uk-nhs-dcb0160` once per site with separate `clinical-safety/deployment/{site-slug}/` subdirectories rather than trying to cover all sites in one case. ## Suggested Next Steps After completing this command, consider running: - `$arckit-uk-nhs-dcb0129` -- Manufacturer-side companion. Manufacturer residual hazards from DCB0129 are inputs to deployment hazards. - `$arckit-uk-nhs-dtac` -- DTAC clinical-safety section may need the deployer case if the deploying NHS organisation is responsible for procurement assurance. - `$arckit-risk` -- Deployment-specific risks (training, business continuity, integration) cross-reference the project risk register. - `$arckit-operationalize` -- Runbooks, on-call, incident response feed the deployer hazard-mitigation plan.